Academic sees jail time loophole in new drug safety laws

A new drug safety law has lowered the maximum jail sentence for makers of counterfeit and substandard drugs from three years to two, says a University of Ottawa professor.

A new maximum penalty of five years requires a near-impossible legal test, making it obsolete in the fight against falsified pharmaceuticals, said Amir Attaran, an associate professor and advocate for stronger counterfeit laws.

“If you can’t clear that hurdle, and this is going to be 99.9 percent of cases, this government just cut imprisonment from three years to two,” said Attaran.

Courts will have to rely on new sections of the Food and Drugs Act that aren’t built for tackling counterfeit and substandard drugs, which leaves them with a maximum sentence of two years in jail, he said.

The current maximum penalty under the act is three years.

The legal opinion is at odds with the Conservative government’s tough-on-crime agenda, a natural fit with Canada’s abysmal track record on prosecuting those who make and traffic imitation drugs.

In a one-week sting in 2013, Canadian officials netted 238,000 units of counterfeit drugs — a unit representing one tablet or pill. In the last two thirds of 2014, they intercepted around 4,700 counterfeit drug shipments.

But for all this, there have been zero prosecutions under the Food and Drugs Act for making or selling counterfeit drugs, a finding in the Senate Committee on Social Affairs, Science and Technology’s report Prescription Pharmaceuticals in Canada: Unintended Consequences, released in October.

Health Minister Rona Ambrose touted Vanessa’s Law, a sweeping set of changes to the act that received Royal Assent in November, as a fix to the problem when she responded to the committee by letter on March 26.

“This is the greatest change to the Food and Drugs Act in 50 years,” said Conservative MP Terence Young, who began advocating for new drug safety laws after his daughter Vanessa died from taking a Johnson & Johnson drug called Propulsid in 2000.

Vanessa’s Law gives Ottawa new recall powers and allows the courts to issue injunctions. In its wake, Ambrose launched an online database on drug shortages in February and another on plant inspections this week. Young points to the new penalties for drugs that have unintended side effects and increased transparency for clinical trials.

While these changes can make life harder for big drug companies, Attaran argues that two new parts to the Food and Drugs Act’s section on offences will lower the potential jail time makers of counterfeit or substandard drugs could face.

Under the old law, section 31 was brought into play by section eight, which says no one can contravene the act by a making or keeping a drug under unsanitary conditions or that is adulterated, the legal term for a counterfeit or substandard drug. Section 31, which still exists in the new law, says an indictable offence leads to a fine no bigger than $5000 or a jail term no bigger than three years.

The first new section is section 31.2, which creates a new set of rules for a contravention under the act for “offences relating to therapeutic products,” which includes drugs. The maximum penalty for an indictable offence is a $5 million fine, two years in jail or both.

The second amendment is section 31.4, which spells out for the first time the notion of someone “knowingly or recklessly causes a serious risk of injury to human health” through a contravention of the act. The maximum penalty in this case is a fine at the court’s discretion, a five-year stint in jail or both.

These new sections offer detail on the criminal consequences someone might face for disrespecting Canada’s drug laws, a key selling for proponents of Vanessa’s Law.

“The legislation increased fines and prison terms that can be imposed by a court on conviction for an offence under the act,” wrote Patrick Gaebel, a spokesperson for Health Canada, in an email.

While the fines have been considerably increased, the highest available prison term – five years – is practically useless, said Attaran.

In some cases, connecting a bad drug to someone’s injury or death in a courtroom could be relatively easy. The effect of a counterfeit or substandard tissue plasminogen activator (TPA), which is ingested during a heart attack, could easily be proven, said Attaran.

“It’s going to happen within hours, so it’s easy to make the connection,” he said.

But in the vast majority of cases, a drug’s quality can’t be so easily linked to life and death. The estimate for a person’s survival under a type of cancer therapy can vary considerably, which means proving a drug was behind a death can be impossible, he said.

Even if the link can be proven, section 31.4 requires proving an intent to harm patients, said Attaran.

“Proving that there is an intent to risk health is very, very, very hard,” he said. “It can almost never be done, you need someone almost in the TPA case.”

The result is that prosecutions only under section the new section 31.2 are likely, which means two years in jail, said Attaran.

Before subsections 31.2 and 31.4 were introduced, a contravention under section eight would kick section 31 into play without going any further, meaning the three year sentence maximum could be used, said Attaran.

Section 31 still exists in the Food and Drugs Act. But because section 31.2 explicitly applies to therapeutic products, it will override section 31, he said.

“These guys didn’t prosecute the crime even when it was easy to do and you didn’t need to prove the intent to harm,” said Attaran. “Now they’ve added this intent-harm requirement, making it harder and at the same time rolling back the imprisonment where they can’t prove that.”

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